OTC Drug Facts Label Review (Monograph Conformity)
A review of your OTC Drug Facts label and claims against FDA's format rules and the relevant monograph.
- Signed by a qualified safety assessor
- Regulator-ready, or we revise it free
- Delivered in 24, 48 or 72 hours
Trusted by brands including
Service details
Everything included, explained
Quick answer
OTC drugs such as sunscreens, acne treatments and antiperspirants must carry a Drug Facts label in the format set by 21 CFR 201.66, with wording that matches the relevant OTC monograph. We review active ingredients, uses, warnings, directions, claims and the principal display panel, and mark up required changes. Laboratory testing is excluded. £795 per SKU.
What's included in your Drug Facts review
| Document | What it is |
|---|---|
| Format check | Headings, order, type size and layout under 21 CFR 201.66 |
| Monograph conformity | Active ingredient, strength, uses and warnings against the monograph |
| Claims check | Claims beyond the monograph flagged |
| Principal display panel | Identity, net quantity and, for sunscreens, SPF and broad spectrum statements |
| Recheck | One recheck of the revised label |
Who this review is for
- Brands selling sunscreen, acne, antiperspirant or anti-dandruff products in the US
- UK and EU brands converting labels for the US
- Amazon US sellers asked to fix drug labels
What this review does not include
- Laboratory testing. Laboratory testing, lab fees and test reports are not included. SPF, broad spectrum and water resistance claims need test evidence.
- Label design.
- Registration and listing. Available separately.
- Non-monograph drugs needing an NDA.
How it works
- Send your label Every panel, the formula and test reports for claims.
- Review We check format, monograph wording and claims.
- Report You receive a marked-up label.
- Recheck One recheck is included.
What is a Drug Facts label?
Every OTC drug in the US must carry a Drug Facts panel in the standard format of 21 CFR 201.66: active ingredients, purpose, uses, warnings, directions, other information and inactive ingredients. Wording must match the applicable OTC monograph under FD&C Act section 505G, such as M020 for sunscreens or M019 for antiperspirants. Sunscreen claims like SPF, broad spectrum and water resistant need test evidence.
What we check
Drug Facts:
- Active ingredient and purpose.
- Uses and warnings in monograph wording.
- Directions and inactive ingredients.
Front of pack:
- Statement of identity and net quantity.
- Claims supported by the monograph and your test data.
What you receive
- Marked-up Drug Facts and pack review
- List of required changes
- One recheck
Legal framework
- 21 CFR 201.66 — Drug Facts format and content
- FD&C Act section 505G — OTC monographs
- OTC Monograph M020 — sunscreen drug products
- OTC Monograph M019 — antiperspirant drug products
Official sources:
Why brands choose Phoenix
- Monograph wording checked line by line.
- Claims risk flagged.
- Recheck included.
- Reviewed by Syed Muhammad Shamuel Shees, US Regulatory Lead.
Get your Drug Facts right first time. Order above, or message us on WhatsApp on +44 7346 009332.
Frequently asked questions
What must a Drug Facts label include?
Active ingredients, purpose, uses, warnings, directions, other information and inactive ingredients, in the format set by 21 CFR 201.66.
Can I use my EU sunscreen label in the US?
No. US sunscreens are OTC drugs and need a Drug Facts label that matches the sunscreen monograph.
Is SPF testing included?
No. Laboratory testing, lab fees and test reports are not included.
What is an OTC monograph?
FDA's rules for a category of OTC drugs, setting allowed active ingredients, strengths, uses and label wording.
Is a recheck included?
Yes, one recheck of the revised label.
How much does the review cost?
£795 per SKU.